Cleared Traditional

Withings ECG App

K240795 · Withings · Cardiovascular

Jun 2025

Decision

450d

Days

Class 2

Risk

About This 510(k) Submission

K240795 is an FDA 510(k) clearance for the Withings ECG App, a Electrocardiograph Software For Over-the-counter Use (Class II — Special Controls, product code QDA), submitted by Withings (Issy-Les-Moulineaux, FR). The FDA issued a Cleared decision on June 15, 2025, 450 days after receiving the submission on March 22, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2345.

Submission Details

510(k) Number	K240795 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 2024
Decision Date	June 15, 2025
Days to Decision	450 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	QDA — Electrocardiograph Software For Over-the-counter Use
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2345
Definition	An Electrocardiograph Software Device For Over-the-counter Use Creates, Analyzes, And Displays Electrocardiograph Data, And Can Provide Information For Identifying Cardiac Arrhythmias. This Device Is Not Intended To Provide A Diagnosis.